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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03760926

NCT03760926
Completed Not Applicable

Who may be able to join

Who might be able to join this trial:

  • You are a woman aged between 18 and 40 years old

  • You have been diagnosed with Polycystic Ovary Syndrome (PCOS), confirmed by at least 2 of these 3 signs: irregular or infrequent periods (35+ days between periods, or 9 or fewer periods per year); ovaries that appear enlarged or have many follicles on an ultrasound scan; signs of higher-than-normal male hormones, either through symptoms like excess hair growth or acne, or through a blood test result

  • Your ovaries can be reached by an internal (transvaginal) ultrasound probe

  • You have not responded to standard medication to trigger ovulation — specifically, at least 2 treatment cycles without ovulation, including at least one cycle at the highest suitable dose

  • At least one of your fallopian tubes is open and your womb appears normal, confirmed by a relevant scan or procedure within the last 3 years

  • You are willing to attend all required follow-up appointments as set out in the study plan

  • You have read and signed a consent form agreeing to take part

  • Your partner has normal sperm results based on standard measures (concentration, movement, and shape)

  • You and your partner are able to have regular intercourse during the study

  • Neither you nor your partner has had a sterilisation procedure (such as vasectomy or tubal ligation) that was later reversed

Who may not be able to join:

  • You are currently pregnant, have recently given birth, or are breastfeeding
  • Your Body Mass Index (BMI) is above 35 (considered severely obese)
  • Your male hormone levels are very high (confirmed with trial site)
  • You have previously had surgery on your ovaries, including for endometriosis, ovarian cysts, or a procedure called LOD, or you are known or suspected to have scar tissue around your ovaries
  • You have a pacemaker, defibrillator, or any other active medical implant in your body
  • You are currently taking part in another clinical trial that could affect the results of this study
  • You are not able to give informed consent freely — for example, if you are under guardianship or a legal protection order, or are unable to express your agreement to participate

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
May Health
Registry
clinicaltrials_gov
Start date
14 February 2019
Est. completion
2 September 2023

Where this trial is recruiting

🇧🇪 Belgium 🇫🇷 France 🇬🇧 United Kingdom

Primary endpoints

Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications; Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov